The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend.
| Device ID | K170763 |
| 510k Number | K170763 |
| Device Name: | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend |
| Classification | Mesh, Surgical |
| Applicant | ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046 |
| Contact | Salman Elmi |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington Dc, DC 20004 |
| Product Code | FTM |
| Subsequent Product Code | OXH |
| Subsequent Product Code | OXK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001783 | K170763 | 000 |
| 00386190001776 | K170763 | 000 |
| 00386190001639 | K170763 | 000 |
| 00386190001622 | K170763 | 000 |
| 00386190001615 | K170763 | 000 |
| 00386190001608 | K170763 | 000 |